RTC 24-VP Universal Metered Dose Inhaler Adapter - The Instrumentation Industries, Inc. RTC 24-VP - INSTRUMENTATION INDUSTRIES, INCORPORATED

Duns Number:053146767

Device Description: The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-VP MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-VP MDI Adapter is Critical Care and/or long term or short term ventilation.The RTC 24-VP MDI Adapter is intended for single patient reuse. This device is intended for sale by or on the order of a physician.

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More Product Details

Catalog Number

-

Brand Name

RTC 24-VP Universal Metered Dose Inhaler Adapter

Version/Model Number

RTC 24-VP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101857,K101857,K101857

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

25a09157-3d6f-4a56-b32a-0834d487c49b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 24, 2016

Additional Identifiers

Package DI Number

M996RTC24VP4

Quantity per Package

25

Contains DI Package

M996RTC24VP0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ziplock Bag

"INSTRUMENTATION INDUSTRIES, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 229
2 A medical device with a moderate to high risk that requires special controls. 71